BIO Testifies at 21st Century Cures Hearing on PCAST

Today, BIO’s Executive Vice President of Health Sara Radcliffe presented testimony to the U.S. House of Representatives Energy and Commerce Subcommittee on Health Hearing.

The Hearing focused on the President’s Council of Advisors on Science and Technology (PCAST) Report on Drug Innovation and key issues related to the 21st Century Cures initiative to examine what steps the Committee can take to accelerate the pace of cures in America.

Below is a summary:

The Challenge of Chronic and Debilitating Disease: Chronic disease increasingly will drive health care costs in the future. It is therefore a national imperative that we find new treatments and cures. This can only be accomplished if we as a nation establish and defend policies that protect intellectual property, promote the effective transfer of new technology, enable regulatory agencies to keep pace with science, encourage the development and adoption of modern approaches to drug development, and continue to invest in scientific research. We cannot afford to lose the next generation of discoveries that address one of the nation’s leading cost drivers – chronic and debilitating disease.

The Challenge of Global Competition: We are facing unprecedented global competition to remain the world leader in biomedical research. America has developed more cures and breakthrough medicines than any other country and is home to over 2,500 biotech companies. However, this is not a position that will be sustained without continued investment and policies focused on supporting and incentivizing the next generation of biomedical discoveries, treatments, and cures. Only by continuing to invest in the biomedical research and development ecosystem will we maintain global leadership, be in a position to increase U.S. jobs, and ensure that all Americans have access to the benefits of biomedical innovation.

The Challenge of Economic and Job Growth: Life science R&D and the biopharmaceutical industry provide high-wage jobs both at public research institutions and in the biotech companies located near centers of academic research. The indirect effects of increased research funding on regional economies are significant. Continuing this pattern of job creation is crucial and will require continued and renewed commitment to forward-thinking policies that will allow this to happen. This clearly is a particular challenge in the current budget climate, but we cannot afford not to take creative steps to meet that challenge.

Radcliffe also shared key considerations across the drug development spectrum, including:

Discovery: Funding for the National Institutes of Health, supporting the National Center for Advancing Translational Sciences, FDA funding

Development: Confronting the problem of increasing costs and durations of clinical trials is a daunting task. The biotechnology industry is committed to partnering with Congress, FDA, NIH, patients, academia and other stakeholders to make meaningful progress toward improving the conduct of clinical trials. More efficient clinical trials translate to reduced barriers to market for safe, innovative medicines the ultimate goal of patients and industry.

BIO launched its Clinical Trial Modernization Initiative (CTMI) in 2012, based on the pillars of four initial priority issues, which were also highlighted in the PCAST report:

Use of Centralized Institutional Review Boards (IRBs)

Improving the FDA Qualification Process for Drug Development Tools

Promotion of Clinical Trial Networks and Partnerships

Risk-Based Approaches to Clinical Trial Monitoring

Radcliffe also highlighted the expansion of accelerated approval; establishment of breakthrough therapy and special medical use designation; timely, interactive communication during drug development; patient focused drug development; and management practices at FDA.

Delivery: Radcliffe closed with highlighting the importance of collecting post-market real world data and addressing reimbursement.

The principles that guide our work in reimbursement include quality, patient impact, access, adherence, importance of incentivizing innovation, evidence, transparency, and adequate reimbursement.